AccessGUDID - DEVICE: SonoInject Catheter HSG (00850011427187)

GUDID

Device Identifier (DI) Information

Brand Name: SonoInject Catheter HSG
Version or Model: 61-2005 HSG
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 61-2005 HSG
Company Name: TITUS MEDICAL LLC

Primary DI Number: 00850011427187
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080306309 *Terms of Use

Device Description: SIS or HSG single Lumen Catheter 5fr

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
15622	Uterine injector	A hand-held manual device designed to inject/administer liquids into the uterus and/or fallopian tubes, typically contrast medium during radiographic procedures to evaluate tubal patency. It is typically used in conjunction with an appropriate intrauterine catheter which may be manipulated through an external mechanism. The injector may be used to manipulate or reposition the uterus during diagnostic and/or surgical procedures. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LKF	Cannula, Manipulator/Injector, Uterine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092969	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 89d76a9b-7359-44a7-948b-15ca6bf11ce0
Public Version Date: April 08, 2024
Public Version Number: 1
DI Record Publish Date: March 31, 2024